← FDA Drug Approvals (Drugs@FDA)
BICALUTAMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: FRESENIUS KABI USA · Approved 2010-05-13
Drug application
- FDA Application #
ANDA079045
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BICALUTAMIDE
- Generic name
- Bicalutamide
- Active ingredients
- BICALUTAMIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- FRESENIUS KABI USA
- First approval
- 2010-05-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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